The guidance, issued on July 28, explains that the FDA does not intend to actively regulate low-risk technologies that are intended only for general wellness use. The FDA encourages the development of general wellness technologies, such as fitness trackers or mobile apps, which can empower individuals to take a more active role in their health. The FDA will continue to focus its oversight on medical devices that may pose inherent risks to a user’s safety.

Key changes from the draft guidance include:

Clarifying that CDRH’s general wellness policy does not apply to devices that present risks to users’ or other persons’ safety.

Identifying where the FDA will continue to focus oversight. The FDA does not consider a general wellness product to be low risk if any of the following apply:

Is the product invasive?

Is the product implanted?

Does the product involve technology that may pose a risk to a user’s safety if regulatory controls are not applied, such as risks from lasers, radiation exposure, or electrical stimulation?

If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.

Thank you,

Food and Drug AdministrationCenter for Devices and Radiological Health